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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||EW9127 / 1||LA / OT|
Administered by: Other Purchased by: ??
Symptoms: Body temperature, Hypotonic-hyporesponsive episode, Myocardial infarction, Pyrexia, Breath sounds abnormal
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Diagnostic Lab Data: Test Date: 20210417; Test Name: Body temperature; Result Unstructured Data: Test Result:39-39.4 degree Celsius Centigrade; Test Date: 20210417; Test Name: Body temperature; Result Unstructured Data: Test Result:increased up to 39 Centigrade; Test Date: 20210417; Test Name: Body temperature; Result Unstructured Data: Test Result:dropped to 36.6 Centigrade
CDC 'Split Type': PLPFIZER INC2021554031
Write-up: Hypotonic-hyporesponsive episode; Fever/fever 39-39.4 C/dropped to 36.6 degrees C; Breath sounds abnormal; Myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number PL-URPL-3-630-2021. A 72-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 14Apr2021 20:29 (Lot Number: EW9127; Expiration Date: 18Apr2021) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced myocardial infarction and breath sounds abnormal on 17Apr2021, hypotonic-hyporesponsive episode and fever on 17Apr2021 07:00. Additional information: Reaction date 17Apr2021 at 07:00. In the submitted adverse reaction report the following symptoms were listed after the vaccination: fever 39-39.4 C, up to 24 hours; hypotonic-hyporesponsive episode. Description of the reaction: On 17Apr2021, the patient''s body temperature increased up to 39 degrees C. After administration of Paracetamol, the temperature dropped to 36.6 degrees C. The woman fell asleep. It was impossible to wake her up, she was snoring. An ambulance was called. The patient died in the hospital on April 18 at 00:30. Autopsy Cause of Death: Myocardial Infarction. Application at the request of the family. The outcome of events was fatal. The patient died on 18Apr2021. Sender''s comment: Pyrexia is an expected side effect as described in the regulatory authority and may occur following the administration of Comirnaty vaccine. The report includes a hypotonic-hyporesponsive episode, which, according to the definition, occurs among children under 2 years old. The report concerns an adult. The episode was marked by a physician because the undesirable post-vaccination reaction report does not provide a possibility to select the appropriate symptoms for adults. According to the regulatory authority, hypotonic-hyporesponsive episode among adults should not be taken into account in the assessment. In such a case, it is symptoms that should be assessed: syncope or presyncope state. Myocardial infarction is an effect not expected with Comirnaty vaccine. Until May 10, 2021, the regulatory authority database has had 133 cases of myocardial infarction reported, including 59 fatal cases. Snoring is not an expected reaction to the vaccine. Breathing sounds abnormal have been reported in the regulatory authority database. The regulatory authority does not have information about the patient''s medical history, only the cause of death is known, which was determined as a result of an autopsy. There is a time relationship between the administration of the vaccine and the occurrence of side effects. The reporting person qualified undesirable post-vaccination reaction as heavy. The regulatory authority assessed the undesirable post-vaccination reaction as heavy. Relatedness of drug to reaction(s)/event(s):Hypotonic-hyporesponsive episode, Source of assessment - regulatory authority, Method of assessment - regulatory authority, Result of Assessment - Unclassifiable Relatedness of drug to reaction(s)/event(s): Myocardial infarction, Source of assessment, Method of assessment - regulatory authority, Result of Assessment - Possible Relatedness of drug to reaction(s)/event(s): Fever, Source of assessment - Regulatory Authority, Method of assessment - regulatory authority, Result of Assessment - Probable Relatedness of drug to reaction(s)/event(s): Breath sounds abnormal, Source of assessment - Regulatory Authority, Method of assessment - regulatory authority, Result of Assessment - Possible No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Hypotonic-hyporesponsive episode; Fever; Breath sounds abnormal; Autopsy-determined Cause(s) of Death: Myocardial infarction
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